Fenofibrate 43mg Capsules

Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARα), a nuclear receptor that regulates lipid metabolism. Through activation of PPARα, fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III (an inhibitor of lipoprotein lipase activity). It also increases the synthesis of apolipoproteins A-I and A-II, which are components of HDL-C.

Important Side Effects to Report to Your Doctor Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention immediately:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Gallstones: Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin or eyes, or fever with chills.
Severe joint pain or swelling: If you experience very bad joint pain or swelling, contact your doctor right away.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if you feel very tired or weak or have a fever. This can also lead to kidney problems. Inform your doctor if you have difficulty urinating or notice a change in your urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Contact your doctor right away if you experience signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only have minor ones. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:

Headache
Back pain
Stomach pain

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as gallbladder disease, kidney disease, liver disease, or elevated liver enzymes.
If you are taking any of the following medications: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.
If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication, and you may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you verify that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor to monitor your condition. Adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your health.

Be aware that this medication can cause liver problems, which in some cases may be severe and potentially life-threatening, requiring a liver transplant or resulting in death. If you have any concerns or questions, discuss them with your doctor.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects.

If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.

• Cyclosporine (increased risk of renal dysfunction)
• Colchicine (increased risk of myopathy/rhabdomyolysis)

• Statins (HMG-CoA reductase inhibitors) - increased risk of myopathy, rhabdomyolysis, and renal failure. Use with caution, monitor for muscle pain.
• Oral anticoagulants (e.g., Warfarin) - potentiates anticoagulant effect, increased risk of bleeding. Reduce anticoagulant dose and monitor INR frequently.
• Bile acid sequestrants (e.g., Cholestyramine, Colestipol) - may reduce absorption of fenofibrate. Administer fenofibrate 1 hour before or 4-6 hours after bile acid sequestrants.

• Fibrates (other) - concomitant use not recommended due to increased risk of adverse effects.
• Glitazones (e.g., Pioglitazone, Rosiglitazone) - potential for additive effects on lipid parameters, monitor closely.

• Not available

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise) - indicative of myopathy/rhabdomyolysis.
• Severe abdominal pain, nausea, vomiting - indicative of pancreatitis or gallstones.
• Yellowing of skin or eyes (jaundice), dark urine, light-colored stools, persistent fatigue - indicative of liver injury.
• Signs of bleeding (e.g., unusual bruising, nosebleeds, blood in urine/stools) - especially if on anticoagulants.

Fenofibrate is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Lipid-lowering drugs are generally not recommended during pregnancy as cholesterol and cholesterol derivatives are essential for fetal development.

It is not known whether fenofibric acid is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Generally, breastfeeding is not recommended.

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Renal function should be monitored.

• Fenofibrate 43mg (Lipofen) is a micronized formulation designed for improved absorption, especially when taken with food. It is not interchangeable on a mg-per-mg basis with other fenofibrate formulations (e.g., TriCor, Triglide) due to differences in bioavailability.
• Always take fenofibrate 43mg capsules with meals to optimize absorption.
• Regular monitoring of liver function tests (LFTs) and renal function is crucial, especially during the first year of therapy.
• Educate patients on the signs and symptoms of myopathy (muscle pain, tenderness, weakness) and pancreatitis (severe abdominal pain) and to report them immediately.
• Fenofibrate can potentiate the effects of warfarin; close INR monitoring and warfarin dose adjustment are necessary when initiating or discontinuing fenofibrate.
• Not indicated for the primary prevention of cardiovascular disease, but rather for the treatment of dyslipidemia.

• Other Fibrates (e.g., Gemfibrozil, Fenofibrate (other formulations like TriCor, Triglide))
• HMG-CoA Reductase Inhibitors (Statins) (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - primary for LDL-C lowering, but some also lower triglycerides.
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - for severe hypertriglyceridemia.
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - primarily for LDL-C lowering.
• Niacin (Nicotinic Acid) - for mixed dyslipidemia, but often limited by side effects.
• Bempedoic Acid (with or without Ezetimibe) - for LDL-C lowering.
• Diet and lifestyle modifications (cornerstone of dyslipidemia management).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.